Container and cap for a biological specimen

ABSTRACT

A container for collecting a biological specimen is provided that includes a peripheral wall extending from a base. The container further includes a longitudinal tower disposed within the container. The tower forms a partition within the container to form at least a first chamber and a second chamber therein, wherein the first and second chambers are in fluid communication with one another. In addition, the container include an insert disposed within the container opposite the base, the insert comprising at least a first opening and a second opening. The second opening provides access to the second chamber and is further configured to engage a specimen collecting device to leave a portion of the specimen collecting device within the second chamber. The first opening provides access to the first chamber and is further configured to receive a syringe therein for accessing the biological specimen. Associated systems and methods are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/672,205, filed on Nov. 8, 2012, which claims the benefit ofthe filing date of U.S. Provisional Patent Application No. 61/557,011filed Nov. 8, 2011, the disclosures of which are hereby incorporatedherein by reference.

BACKGROUND OF THE INVENTION

Embodiments of the present invention relate generally to a container, anassembly, a system, and a method for collecting a biological specimen,such as cytological samples.

Specimen containers, such as vials and associated caps, are routinelyused for collecting biological specimens, such as cytological samples.For example, a biological specimen may be obtained from the cervix orvagina using a brush in conjunction with a pap smear test to screen forand detect cervical cancer, pre-cancerous lesions, atypical cells, andother cytological categories. The brush may then be placed in the vialso as to transfer the sample into the vial for subsequent processing andanalysis (e.g., vortex mixing, aspiration, and slide analysis). In someinstances, the brush is detachable and left in the vial.

Undesirable materials, however, such as mucous, may adhere to the brushwhen obtaining the sample, thereby being deposited in the vial, whichcan interfere with subsequent processing. As such, a need exists for anapparatus configured to minimize the interference from undesirablematerials, such as mucous, that facilitates the collection andprocessing of a biological sample.

BRIEF SUMMARY OF THE INVENTION

Various embodiments of the present invention are directed to acontainer, an assembly, a system, and a method for collecting abiological specimen. In one embodiment, a container for collecting abiological specimen is provided. The container may include a peripheralwall extending from a base, wherein the peripheral wall and base definean interior surface and an exterior surface. The container may furtherinclude a longitudinal tower disposed within the container, wherein thetower forms a partition within the container to form at least a firstchamber and a second chamber therein, wherein the first and secondchambers are in fluid communication with one another. In someembodiments, the container may include an insert disposed within thecontainer opposite the base, the insert comprising at least a firstopening and a second opening defined therein, wherein the second openingis configured to provide access to the second chamber and is furtherconfigured to engage a specimen collecting device to thereby leave aportion of the specimen collecting device within the second chamber, andwherein the first opening is configured to provide access to the firstchamber and is further configured to receive a syringe therein foraccessing the biological specimen.

In some embodiments, the container may further comprise a notch definedin the exterior surface and configured to position the apparatus insubsequent processing. The container may further include a towerdisposed within the container such that the first chamber is locatedapproximately radially opposite from the notch. In some embodiments, thetower may further comprise a base edge adjacent to the base and at leasttwo longitudinal edges extending therefrom and to the insert, whereinthe base edge and the at least two longitudinal edges do not contact theinterior surface of the peripheral wall. According to some embodiments,the base may be sloped downwards towards the base edge of the tower.

According to some embodiments, the first and second chambers may be influid communication with one another along the entire length of the atleast two longitudinal edges of the tower. In some embodiments, theinsert may be integrally formed with the interior surface of theperipheral wall of the container. The top edge of the tower may becoupled to the insert. In some embodiments, the first chamber may have avolume smaller than the volume of the second chamber. In someembodiments, the peripheral wall may be cylindrical in shape. Further,the longitudinal tower may extend parallel to the longitudinal axis ofthe peripheral wall. In some embodiments, the first and second openingsof the insert might not be in fluid communication with one another.

In some embodiments, a system for collecting a biological specimen isprovided. The system may comprise a container for collecting abiological specimen comprising a peripheral wall extending from a base,wherein the peripheral wall and the base define an interior surface andan exterior surface. The system may further include a longitudinal towerdisposed within the container, wherein the tower forms a partitionwithin the container to form at least a first chamber and a secondchamber therein, wherein the first and second chambers are in fluidcommunication with one another. In some embodiments, the system mayinclude an insert disposed within the container opposite the base, theinsert comprising at least a first opening and a second opening definedtherein, wherein the second opening is configured to provide access tothe second chamber and is further configured to engage a specimencollecting device to thereby leave a portion of the specimen collectingdevice within the second chamber, and wherein the first opening isconfigured to provide access to the first chamber and is furtherconfigured to receive a syringe therein for accessing the biologicalspecimen. According to some embodiments, the system may further includea cap configured to cover the first and second openings and sealinglyengage the peripheral wall, the cap including at least one engageablemember configured to be engaged for securing and unsecuring the cap tothe container.

In some embodiments, the system may include a specimen collecting deviceconfigured to obtain a biological specimen from a patient and transferthe biological specimen to the container. In addition, the specimencollecting device may include a container having a peripheral wall thatfurther comprises a flange and a threaded exterior surface disposedopposite from the base. The container may include a notch defined by theexterior surface and configured to position the system in subsequentprocessing. According to some embodiments, the tower may furthercomprise a base edge adjacent to the base and at least two longitudinaledges extending therefrom and to the insert, wherein the base edge andat least the two longitudinal edges do not contact the interior surfaceof the peripheral wall. The base may be sloped downwards towards thebase edge. In some embodiments, the first and second chambers may be influid communication with one another along the entire length of the atleast two longitudinal edges.

According to some embodiments, the insert may be integrally formed withthe interior surface of the peripheral wall of the container. The topedge of the tower may be coupled to the insert. In some embodiments, thelongitudinal tower may extend parallel to a longitudinal axis of theperipheral wall. The system may further include an insert comprising afirst and second opening defined therein, wherein the first and secondopenings are not in direct fluid communication with one another. In someembodiments, the cap including at least one engageable member configuredto be engaged by a chuck for securing and unsecuring the cap to thecontainer may include an engageable member comprising a plurality offingers equally-spaced around and extending inwards from thecircumference of the cap. The plurality of fingers may be configured tobe engaged by a chuck for securing and unsecuring the cap to thecontainer. According to some embodiments, the cap may comprise a centralportion that is configured to be pierceable by a piercing instrument.

According to some embodiments, a method for collecting a biologicspecimen is provided. The method may include obtaining a biologicalspecimen with a biological specimen device. The method may furtherinclude inserting the biological specimen device into a container, thecontainer comprising a peripheral wall extending from a base, whereinthe peripheral wall and the base define an interior surface and anexterior surface. In some embodiments, the container may include alongitudinal tower disposed within the container, wherein the towerforms a partition within the container to form at least a first chamberand a second chamber therein, wherein the first and second chambers arein fluid communication with one another. According to some embodiments,the container may further include an insert disposed within thecontainer opposite the base, wherein the insert comprises at least afirst opening and a second opening defined therein, wherein the secondopening is configured to provide access to the second chamber and isfurther configured to engage a specimen collecting device to therebyleave a portion of the specimen collecting device within the secondchamber, and wherein the first opening is configured to provide accessto the first chamber and is further configured to receive a syringetherein for accessing the biological specimen.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily drawn toscale, and wherein:

FIG. 1 illustrates a specimen container assembly configured forcollecting a biological specimen according to some embodiments of thepresent invention;

FIG. 2 illustrates a container configured for receiving and storing abiological specimen according to some embodiments of the presentinvention;

FIG. 3 illustrates a top view of the container shown in FIG. 2 accordingto some embodiments of the present invention;

FIG. 4 illustrates a container configured for receiving and storing abiological specimen according to some embodiments of the presentinvention;

FIG. 5 illustrates a top view of the container shown in FIG. 4 accordingto some embodiments of the present invention;

FIG. 6A illustrates a specimen container engaged with a samplingapparatus according to some embodiments of the present invention;

FIG. 6B illustrates a specimen container engaged with a samplingapparatus according to some embodiments of the present invention;

FIG. 6C illustrates a specimen container engaged with a samplingapparatus according to some embodiments of the present invention;

FIG. 7 illustrates a cap according to some embodiments of the presentinvention;

FIG. 8 illustrates a cap engaged with a chuck configured to disengagethe cap from the specimen container according to some embodiments of thepresent invention;

FIG. 9 illustrates a sectional view of the cap engaged with a chuckshown in FIG. 8 according to some embodiments of the present invention;

FIG. 10 illustrates a sectional view of the specimen container assemblyconfigured for collecting a biological specimen according to someembodiments of the present invention; and

FIG. 11 illustrates a specimen container engaged with a specimencollection device according to some embodiments of the presentinvention.

DETAILED DESCRIPTION

Embodiments of the present invention will now be described more fullyhereinafter with reference to the accompanying drawings, in which some,but not all embodiments of the invention are shown. Indeed, theseembodiments may be embodied in many different forms and should not beconstrued as limited to the embodiments set forth herein; rather, theseembodiments are provided so that this disclosure will satisfy applicablelegal requirements Like numbers refer to like elements throughout. Theterms top, bottom, side, up, down, upwards, downwards, vertical,horizontal, and the like, to the extent used herein, do not imply arequired limitation in all embodiments of the present invention, butrather are used herein to help describe relative direction and/ororientation in the example embodiments illustrated in the figures.

Various embodiments of the present invention generally provide for anassembly for collecting, identifying, storing and preventingcontamination of a biological sample, wherein the assembly generallyincludes a specimen container and a cap. For example, a specimencontainer may be configured to receive a biological sample therein froma specimen collection device, such as a brush or swab. Accordingly,embodiments of the present invention may facilitate the collectionand/or storage of a biological sample within the container, such as acytological sample obtained from the cervix and/or vagina with aspecimen collection device. In addition, embodiments of the presentinvention may provide for the reduction in contamination of a biologicalspecimen by providing a closed environment for storing the biologicalspecimen. According to some embodiments, the container may be configuredto provide accurate and efficient sample access, handling, and/oridentification, such as during automated processes.

In this regard, FIG. 1 illustrates a specimen sample container assembly10 that includes a container or vial 100 and a cap 200. According to oneembodiment, the vial 100 and cap 200 may be configured to engage oneanother so as to collect, store, seal and/or preserve the specimenwithin the vial. Specifically, the cap 200 may be configured to beremovably coupled to the vial 100 such that when the cap is coupled withthe vial, the vial and cap create a closed and/or sealed environmentpreventing the contamination of a biological specimen stored therein. Assuch, FIG. 1 illustrates the specimen sample container assembly 10according to one embodiment, wherein the vial 100 and cap 200 aresecureably coupled to one another creating such a closed and/or sealedenvironment. In some embodiments, the vial 100 may include a base 102and a perimeter wall 104, as shown in FIGS. 1 and 2. The perimeter wall104 may extend vertically from the base 102 and define an interiorsurface 106 and an exterior surface 108. Although FIG. 2 illustrates anembodiment where the perimeter wall 104 may be cylindrical in shape, oneof ordinary skill in the art may appreciate that the perimeter wall mayinclude a variety of shapes.

FIG. 2 illustrates one embodiment of the present invention that includesa vial 100 having a flange 110 and a threaded surface 112 disposed onthe exterior surface 108 defined by the perimeter wall 104 of the vial.According to one embodiment, the threaded surface 112 may be disposedvertically above the flange 110. The flange 110 and the threaded surface112 may be configured to engage and secure the cap 200 to the vial 100.Although a threaded engagement between the vial 100 and cap 200 isdescribed, it is understood that other engagement mechanisms may beemployed, such as a snap, slotted, or twist-fit connection.

In some embodiments, the vial 100 may further include an alignmentfeature, such as a notch 114. According to some embodiments, the notch114 may be defined, in part, by the perimeter wall 104 of the vial 100.In another embodiment, the notch 114 may be additionally defined, inpart, by the base 102 of the vial 100. The notch 114 may be verticallydisposed proximate to an end of the vial 100 opposite from the threadedsurface 112 and/or flange 110. In some embodiments, the notch 114 mayprovide for orienting the vial 100 in subsequent automated processing,such as for loading the vial in a tray, accessing the contents of thevial and/or the like. For example, the notch 114 may be engaged by acorresponding engagement feature in a tray such that each vial 100placed within the tray is oriented in a similar direction.

In some embodiments, the vial 100 may further include a tower 120 thatextends upwardly from the base 102 of the vial, as shown in FIGS. 1 and2. According to some embodiments, the tower 120 may be configured topartition the interior volume of the vial 100 into two separatechambers. Specifically, the tower 120 may partially define a firstchamber 130 and a second chamber 132 within the vial 100, wherein thefirst and second chambers are in fluid communication with one another.According to some embodiments, the interior surface 106 of the perimeterwall 104 of the vial 100 may cooperate with the tower 120 to furtherdefine the first and second chambers 130, 132. Thus, the interiorsurface 106 and tower 120 may collectively define the first and secondchambers 130, 132. In some embodiments, the first chamber 130 may bedisposed approximately radially opposite from the notch 114.Accordingly, when the vial 100 is aligned in a particular orientationvia the notch 114, the first chamber 130 will always be disposed in aknown position such that access to the first chamber during, forexample, aspiration or mixing of a biological specimen within the firstchamber, will be efficient, repeatable and/or accurate. In someembodiments, the first chamber 130 may have a volume smaller than thevolume of the second chamber 132. However, it is understood that thevolumes of the first and second chambers 130, 132 could be the same orabout the same, or the second chamber may have a smaller volume than thefirst chamber in some circumstances.

The tower 120 may include a top edge 122, as shown in FIG. 2. In someembodiments, the tower 120 may include at least one longitudinal edge126. For example, the tower 120 may have a pair of longitudinal edges onopposite sides thereof, as shown in FIG. 3. In addition, the tower 120may include a base edge 124 (see e.g., FIGS. 1 and 6A-6C). At least onelongitudinal edge 126 may extend vertically upward from the base edge124 of the tower 120. In some embodiments, the base edge 124 of thetower may be spaced apart from the interior surface 106 of the perimeterwall 104 such that the base edge does not contact the perimeter wall.Thus, the base edge 124 of the tower 120 may be formed or otherwisecoupled to a base interior surface 134 of the vial 100 but not theinterior surface 106. According to one embodiment, at least a portion ofthe longitudinal edge 126 may be spaced apart from the interior surface106 of the perimeter wall 104 of the vial 100 so as to define at leastone opening 118 between the first and second chambers 130, 132. FIG. 3illustrates that an opening 118 may be defined along each longitudinaledge 126. As such, the at least one opening 118 provides for fluidcommunication between the first and second chambers 130, 132. In someembodiments, the entire length of the longitudinal edge 126 may bespaced apart from the interior surface 106 of the perimeter wall 104such that the opening 118 also extends along the entire length of thelongitudinal edge. Accordingly, the first chamber 130 and the secondchamber 132 may be in fluid communication with one another along theentire length of the longitudinal edge 126.

Accordingly, a specimen collection device 360, such as a brush, may beplaced within the second chamber 132 such that the vial 100 receives abiological specimen therein, as shown in FIG. 11. In some embodiments,the brush may include a detachable brush head 362 that may be configuredto detach from the specimen collection device and remain within thesecond chamber 132 of the vial 100. According to one embodiment, thetower 120 may be configured to provide access for accessing thebiological specimen via the first chamber 130 without contacting thedetachable brush head of a specimen collection device disposed withinthe second chamber 132 of the vial 100.

According to another embodiment, the vial base 102 may define a baseinterior surface 134 that also defines the first and second chambers130, 132. In some embodiments, the base interior surface 134 may besloped and/or angled towards the tower 120 of the vial 100, as shown inFIG. 10. In some embodiments, the notch 114 may be disposed oppositefrom the tower 120, as shown in FIGS. 1-3 and 10. As such, the baseinterior surface 134 may define a downward slope such that the elevationof the base interior surface 134 disposed proximate to the notch 114 hasa higher elevation than the base interior surface disposed proximate tothe tower 120. Accordingly, the downward slope of the base interiorsurface 134 may provide for as much volume of a specimen to be aspiratedfrom the vial 100, as gravity may assist in encouraging a greaterquantity of the biological specimen to be disposed within the firstchamber 130 of the vial.

FIG. 4 illustrates a vial 100 according to another embodiment of thepresent invention. The vial 100 includes an insert 140 disposed withinthe vial. According to some embodiments, the insert 140 may beintegrally formed with the interior surface 106 of the peripheral wall104 of the vial 100. In some embodiments, the insert 140 may be aseparate component engaged or otherwise coupled to the interior surface106. According to some embodiments, the insert 140 may be a separatecomponent engaged or otherwise coupled with the tower 120. In someembodiments, the insert 140 may be integrally formed with the tower 120,as well as the interior surface 106 of the peripheral wall 104 of thevial 100. As discussed above, the tower 120 defines one or more openings118 along the longitudinal edges. In one embodiment, an opening 118 isalso defined between the base edge 124 of the tower 120 and the baseinterior surface 134. Thus, the tower 120 may not engage the baseinterior surface 134 when engaged with the insert 140.

In some embodiments, the insert 140 may define at least a first opening142 and a second opening 144, as shown in FIGS. 4 and 5. According tosome embodiments, the first opening 142 and second opening 144 are notin direct fluid communication with one another. Thus, the insert 140 maydefine separate openings 142, 144 that are only in fluid communicationindirectly, such as via one or more openings 118 defined between thetower 120 and the interior surface 106 and base interior surface 134.Further, the first opening 142 may be configured to provide access tothe first chamber 130, while the second opening 144 may be configured toprovide access to the second chamber 132. In addition, the secondopening 144 may be shaped such that a portion of the insert 140 extendsbetween the second opening and the interior surface 106 of theperipheral wall 104 of the vial 100. As such, the second opening 144 maybe configured to receive a specimen collection device, such as a brush,swab and/or the like, therethrough. In addition, in an instance where aspecimen collection device 360 includes a detachable portion, such as abrush with a detachable brush head 362, the second opening 144 may beconfigured to assist in detaching the detachable portion of the specimencollection device such that the detachable portion of the specimencollection device remains within the second chamber 132, as shown inFIG. 11. Specifically, the portion of the insert 140 disposed betweenthe second opening 144 and the interior surface 106 of the peripheralwall 104 may define an engagement surface that provides a resistiveforce to the detachable portion of the specimen collection device as thespecimen collection device is being removed from the second chamber 132.For example, a brush 360 with a detachable brush head 362 may beinserted through the second opening 144 to provide the specimen sampleto the vial 100. The brush may then be rotated and pulled upwardly so asto engage the insert 140 and detach the brush head within the vial 100.

As shown in FIGS. 6A-6C, the tower 120 may extend vertically todifferent heights within the vial 100. In this regard, the tower 120 mayextend any desired distance between the base 102 and a top edge of thevial 100. For example, the tower 120 may extend vertically approximatelythree-quarters of the length of the vial 100, as illustrated in FIG. 6A.According to another embodiment, the tower 120 may extend vertically toapproximately the length of the vial 100 from the vial base 102proximate to the flange 110, such as to a horizontal plane that isco-planar with the flange 110 of the vial, as shown in FIGS. 6B and 6C.In addition, the tower 120 may be coupled and/or integrally formed withthe insert 140, while extending from the vial base 102, as shown in FIG.6B. FIG. 6C illustrates one embodiment where the tower 120 extends fromthe vial base 102 proximate to the flange 110, such as to a horizontalplane that is co-planar with the flange 110 of the vial 100 that doesnot include an insert 140. According to some embodiments, the tower 120may extend vertically and parallel to a longitudinal axis of theperimeter wall 104. In addition, the tower 120 may include a generallyC- or U-shaped cross section taken perpendicular to the longitudinalaxis. However, the tower 120 may include different shapes and sizesdepending on the particular specimen to be contained and accessed.

FIG. 7 illustrates a cap 200 configured to engage a vial (such as thosedescribed above) so as to create a sealed and/or closed environment forstoring a biological specimen. Specifically, the cap 200 may include aninterior surface 208, as shown in FIG. 9, configured to engage the outersurface 112 of the vial 100 so as to create a closed environment forstoring the biological specimen. According to some embodiments, theinterior surface of the cap 200 may include a reciprocal threadedinterior surface configured to engage the threaded surface 112 of thevial 100. It is understood that the engagement may be accomplished usingother mechanisms as discussed above, and the threaded engagement couldbe reversed if desired (i.e., the interior surface of the vial may bethreaded and configured to engage a reciprocal cap surface, such as athreaded outer cap surface).

According to some embodiments, the cap 200 may include a pierceablesurface 202. The pierceable surface 202 may include a portion of the cap200 that includes a thinner dimension than other portions of the cap.For example, the pierceable surface 202 may be located generally in acentral portion of the cap 200, although one or more pierceable surfacescould be defined to align with the first and/or second chambers 130,132. As such, the pierceable surface 202 may be configured to be piercedby an instrument, such as a pipette, syringe, needle and/or the like.According to one embodiment of the present invention, the pierceablesurface 202 may be pierced by an instrument such that a specimen may beaspirated from the vial 100 when the vial and cap 200 are sealinglyengaged with one another. Accordingly, the contents of the container 10may be accessed when the vial 100 and cap 200 are sealingly engaged withone another. In some embodiments, the pierceable surface 202 of the cap200 may be pierced so as to allow for the introduction of a specimeninto the container 10 when the vial 100 and cap are sealingly engagedwith one another. In some embodiments, the pierceable surface 202 may bedefined to align with the first chamber 130 such that an instrument,such as a syringe, may pierce the pierceable surface, mix the specimensample, and/or aspirate at least a portion of the specimen withoutcontacting a detachable portion of a specimen collection device, such asa detachable brush head, disposed within the second chamber 132 whilethe vial and cap are sealingly engaged with one another.

In some embodiments, the cap 200 may further include at least one finger204 configured to be engaged by an engagement member, such as a chuck250, as shown in FIG. 8. According to some embodiments, the cap 200 mayinclude at least three fingers 204 equally spaced circumferentiallyaround the cap. Specifically, the fingers 204 may be disposed atapproximately 0, 120, and 240 degrees around the circumference of thecap 200. In some embodiments, the chuck 250 may include at least anequal number of chuck fingers 252 configured to engaged the fingers 204of the cap 200 (e.g., one or more fingers 252). As such, the chuckfingers 252 may engage the fingers 204 so as to disengage the cap 200from the vial 100. In some embodiments, the chuck fingers 252 may beconfigured to engage the fingers 204 of the cap 200 by rotating thechuck fingers in a direction opposite from each of the finger openings206 defined by the respective fingers 204. As shown in FIG. 8, the chuckfingers 252 may rotate in a counter-clockwise direction to engage thefingers 204 of the cap 200, and may rotate in a clockwise direction todisengage the fingers of the cap. In some embodiments, the chuck 250 maybe configured to temporarily disengage the cap 200 from the vial 100while maintaining engagement of the cap, and subsequently re-engage thecap to the vial. According to some embodiments, the chuck 250 may beconfigured to disengage the cap 200 from the vial 100 in an automatedprocess and re-engage the cap to the vial in another automated process.Specifically, the chuck 250 may be configured to disengage the cap 200from the vial 100 to allow for a specimen to be placed, removed,processed and/or otherwise handled within the vial.

According to some embodiments, the container assembly 10 may furtherinclude indicia 370, such as a label, attached thereto, as shown in FIG.2. For example, the indicia may include a visible identifier foridentifying and/or facilitating chain of custody of the containerassembly 10. Specifically, the indicia may include a tear-off portionwith identifying information that corresponds to identifying informationon the indicia remaining on the container assembly 10. In someembodiments, the indicia may include a barcode identifier or otheridentifier on both the portion of the indicia that remains disposed onthe container assembly 10 and the tear-off portion of the indicia.Accordingly, the visual identifier, such as the barcode identifier, mayassist in maintaining chain-of-custody controls while a specimen sampleis tested via an automated processing machine and/or other manualprocesses. According to some embodiments, the tear-off portion of theindicia may be configured to affix to forms and/or documents to be usedfor processing and identification. As such, rather than generatinglabels in a processing center and affixing the labels to both thecontainers 10 and forms and/or other documents, the containers may beprovided to the processing center with the indicia affixed thereto,thereby minimizing potential for mislabeling and other chain-of-custodyissues. Although FIG. 2 illustrates the indicia 370 is shown to beaffixed to the container 100, in some embodiments, the indicia may beaffixed to a container cap 200. In another embodiment, the indicia maybe affixed to both the container vial 100 and the container cap 200.

As such, embodiments of the present invention may provide a number ofadvantages, such as facilitating placement of a specimen and a specimencollection device within the specimen container. For example, accordingto some embodiments, the insert may facilitate placement of a detachableportion of the specimen collection device within one chamber while atower disposed within the container allows for accessing the specimen inanother chamber without disturbing and/or contacting the detachableportion of the specimen collection device. As such, some embodiments ofthe present invention may advantageously prevent cross-contamination ofa specimen sample and/or may advantageously provide for the collectionof the specimen sample without obstruction from a specimen collectiondevice. Moreover, the tower may effectively delineate the container suchthat a portion of the sample is accessible (e.g., with a syringe)without interference from undesirable materials, such as mucous.

In some embodiments, the specimen container assembly may advantageouslyfacilitate the placement of the specimen container within a sample trayconfigured to receive a number of specimen containers. According to someembodiments, an alignment feature, such as a notch, may be configuredsuch that a specimen container including a notch may only be fullyseated within a sample tray when the notch aligns with a reciprocalfeature of the sample tray. Accordingly, the specimen container may bedisposed correctly within a sample tray only when oriented in aparticular fashion. As such, the specimen container may be positionedwithin the sample tray such that a first chamber for accessing thespecimen stored within the container is positioned only at a particularlocation when the specimen container is fully seated within a sampletray. Thus, the specimen container assembly may advantageously provide aknown path for aspirating and/or mixing a specimen sample with a syringeas the specimen container may only be disposed in a particularorientation.

Further, some embodiments of the present invention may advantageouslyprovide for efficient capping and de-capping of a specimen container.For example, a container cap may include a plurality of fingers that areconfigured to engage an engagement member, such as a chuck, such thatthe container cap may be rotated and/or removed from the specimencontainer in an automated process. Some embodiments of the presentinvention may also provide for the engagement member to remain engagedwith the container cap after the cap has been removed to facilitate there-capping of the specimen container after a specimen sample has beenaspirated. As such, some embodiments advantageously provide for aspecimen container to be sealed with a cap previously engaged with thespecimen container to prevent cross-contamination.

Many modifications and other embodiments of the invention set forthherein will come to mind to one skilled in the art to which theseembodiments pertain having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the above-described embodiments are not to be limitedto the specific embodiments disclosed and that modifications and otherembodiments are intended to be included within the scope of the appendedclaims. Although specific terms are employed herein, they are used in ageneric and descriptive sense only and not for purposes of limitation.

1. A container for collecting a biological specimen comprising: a peripheral wall extending from a base, the peripheral wall and base defining an interior surface and an exterior surface; a longitudinal tower disposed within the container, wherein the tower forms a partition within the container to define at least a first chamber and a second chamber therein, wherein the first and second chambers are in fluid communication with one another; and an insert placed over and spanning the longitudinal tower, wherein the longitudinal tower defines a separation between a first portion of the insert over the first chamber and a second portion of the insert over the second chamber, wherein the first portion of the insert is not in fluid communication with the second portion of the insert.
 2. The container of claim 1 wherein the second chamber and the portion of the insert thereover are configured to engage a specimen collecting device to thereby leave a portion of the specimen collecting device within the second chamber, and wherein the first chamber and the portion of the insert formed thereover are configured to receive a device therein for accessing the biological specimen.
 3. A container according to claim 1, further comprising a notch defined in the exterior surface and configured to position the apparatus in subsequent processing.
 4. A container according to claim 3, wherein the tower is disposed within the container such that the first chamber is located approximately radially opposite from the notch.
 5. A container according to claim 1, wherein the tower further comprises a base edge adjacent to the base and at least two longitudinal edges extending therefrom and are spaced apart from the peripheral wall, wherein the base edge and the at least two longitudinal edges do not contact the interior surface of the peripheral wall.
 6. A container according to claim 4, wherein the base is sloped downwards from the notch towards the longitudinal tower.
 7. A container according to claim 4, wherein the first and second chambers are in fluid communication with one another along the entire length of the at least two longitudinal edges.
 8. A container according to claim 1, wherein the longitudinal tower is integrally formed with the interior surface of the peripheral wall of the container.
 9. A container according to claim 1, wherein the first chamber has a volume smaller than a volume of the second chamber.
 10. A container according to claim 1, wherein the peripheral wall is cylindrical in shape.
 11. A container according to claim 1, wherein the longitudinal tower extends parallel to a longitudinal axis of the peripheral wall.
 12. A container according to claim 1 further comprising a cap that seals the interior surface, the cap comprising a pierceable portion located above the first chamber so that a piercing device may pierce the cap and aspirate specimen from the first chamber.
 13. A system for collecting a biological specimen comprising: a container for collecting a biological specimen, the container comprising: a peripheral wall extending from a base, the peripheral wall and base defining an interior surface and an exterior surface; a longitudinal tower disposed within the container, wherein the longitudinal tower forms a partition within the container to form at least a first chamber and a second chamber therein, wherein the first and second chambers are in fluid communication with one another; an insert placed over and spanning the longitudinal tower, wherein the longitudinal tower defines a separation between a first portion of the insert over the first chamber and a second portion of the insert over the second chamber, wherein the first portion of the insert is not in fluid communication with the second portion of the insert; and a cap configured to cover the container and sealingly engage the peripheral wall, the cap including at least one engageable member configured to be engaged for securing and unsecuring the cap to the container.
 14. The system of claim 13 wherein the second chamber is configured to engage a specimen collecting device to thereby leave a portion of the specimen collecting device within the second chamber, and wherein the first chamber is configured to receive a device therein for accessing the biological specimen.
 15. A system according to claim 13, further comprising a specimen collecting device, the specimen collecting device configured to obtain the biological specimen from a patient and transfer the biological specimen to the container.
 16. A system according to claim 13, wherein the peripheral wall further comprises a flange and a threaded exterior surface disposed opposite from the base.
 17. A system according to claim 13 wherein the container further comprises a notch defined by the exterior surface and configured to position the system in subsequent processing.
 18. A system according to claim 13, wherein the tower further comprises a base edge adjacent to the base and at least two longitudinal edges extending therefrom and proximate to the flange, wherein the base edge and at least two longitudinal edges do not contact the interior surface of the peripheral wall.
 19. A system according to claim 17, wherein the base is sloped downwards from the notch towards the longitudinal tower.
 20. A system according to claim 18, wherein the first and second chambers are in fluid communication with one another along the entire length of the at least two longitudinal edges.
 21. A system according to claim 13, wherein the longitudinal tower is integrally formed with the interior surface of the peripheral wall of the container.
 22. A system according to claim 21, wherein a top edge of the tower is coupled to the peripheral wall.
 23. A system according to claim 13, wherein the longitudinal tower extends parallel to a longitudinal axis of the peripheral wall.
 24. A system according to claim 13, wherein the engageable member comprises a plurality of fingers equally-spaced around and extending inwards from the circumference of the cap, the plurality of fingers configured to be engaged by a chuck for securing and unsecuring the cap to the container.
 25. A system according to claim 13, wherein the cap comprises a central portion that is configured to be pierceable by a piercing instrument.
 26. A method for collecting a biological specimen, the method comprising: obtaining a biological specimen with a biological specimen device; and inserting the biological specimen device into a container, the container comprising a peripheral wall extending from a base, the peripheral wall and base defining an interior surface and an exterior surface, the container further comprising: a longitudinal tower disposed within the container, wherein the tower forms a partition within the container to form at least a first chamber and a second chamber therein, wherein the first and second chambers are in fluid communication with one another; and an insert placed over and spanning the tower, wherein the tower defines a separation between a first portion of the insert over the first chamber and a second portion of the insert over the second chamber, wherein the first portion of the insert is not in fluid communication with the second portion of the insert.
 27. The method of claim 26 further comprising: collecting a specimen by engaging a specimen collecting device with the second chamber such that a portion of the specimen collecting device is left within the second chamber when the remainder of the specimen collecting device is removed from the container; receiving a syringe in fluid communication with the biological specimen in the first chamber; and using the syringe to remove at least a portion of the biological specimen from the container. 